Minocycline for Chronic Autoimmune Uveitis

Phase 1

Recruiting

• Conditions: Minocycline; Uveitis; Retinal Degeneration
• Interventions: Drug: minocycline

• Registration Number: NCT05474729
• Lead Sponsor: Sun Yat-sen University

Brief Summary

Autoimmune uveitis is one kind of non-infectious, sight-threatening, relapsing and severe ocular disease. Approximately 20%-25% autoimmune uveitis patients suffer from the dilemma of blindness for the chronic and persistent inflammatory state in the eyes, which results in continuous destroy in the structure of the eyes and gradually leads to irreversible damage on visual function. However, it shows limiting efficacy of current treatment including glucocorticoids, immunosuppressant and biologics for chronic autoimmune uveitis. Minocycline has been regarded to have anti-apoptosis and immunemodulatory function for decades and it has been illustrated to be beneficial in several neuro-degenerative and neuro-inflammatory diseases. This trial aims to investigate the efficacy and safety of minocycline for chronic autoimmune uveitis with retinal degenerative changes.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-01
• Study First Submitted: 2022-07-24
• Study First Submitted QC: 2022-07-24
• Study First Posted: 2022-07-26
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-16
• Last Update Posted: 2023-04-18
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Participant diagnosed of autoimmune diseases with visual function damage (decrease of BCVA, loss of retinal structure)
• Participant aged from 18-60 years old.
• Participant that signed the informed consent document and is able to complete the following visits.

Exclusion Criteria

• Participant is allergy to minocycline or tetracyclines.
• Participant has no contraindications of minocycline or tetracyclines.
• Participant has an abnormal function of liver, heart, kidney and thyroid.
• Participant is using glucocorticoids, immunosuppressants or biologics.
• Female that is pregnant, breast-feeding or planning to become pregnant.
• Participant that is currently using other medications for other diseases.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
minocycline	minocycline	minocycline capsule 100mg per day orally

Primary Outcome Measures

Name	Time	Method
Change of macular sensitivity	At 6 and 12 months	Change of macular sensitivity measured by MAIA
Change of BCVA	At 6 and 12 months	Change of BCVA measured by ETDRS
Change of Visual field	At 6 and 12 months	Change of Visual field measured by HVF 30-2 visual field testing
Changes in Implicit Time and Amplitude of Photopic and Scotopic Responses	At 6 and 12 months	Changes in Implicit Time and Amplitude of Photopic and Scotopic Responses measured by Electroretinogram (ERG) Testing

Secondary Outcome Measures

Name	Time	Method
Change of QoL questionaire	At 6 and 12 months	Change of QoL measured by VFI-25
Change of macular vessel	At 6 and 12 months	Change of macular vessel measured by OCTA
Change of Contrast Sensitivity	At 6 and 12 months	Change of Contrast Sensitivity measured by F.A.C.T
Change of Color Visual	At 6 and 12 months	Change of Color Visual measured by FM100
Number of ocular and non-ocular adverse events Number of ocular and non-ocular adverse events Number of ocular and non-ocular adverse events Number of ocular and non-ocular adverse events Number of Ocular and Non-ocular Adverse Events	At 6 and 12 months

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center; 🇨🇳 Guangzhou, Guangdong, China